Orally Disintegrating Films—Pharmaceutical Development for Improved Bioperformance

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: closed (31 March 2021) | Viewed by 18219

Special Issue Editor


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Guest Editor
University of Belgrade, Belgrade, Serbia
Interests: patient-centric drug product design; oral drug delivery; advanced solid dosage forms; additive manufacturing; bioperformance prediction

Special Issue Information

Dear Colleagues,

Orally disintegrating films (ODFs) have emerged as innovative oral dosage forms which may combine flexible dosing and a high level of medication adherence, thus meeting the criteria for patient-centric drug product design. Although their potential advantages in pharmacotherapy are well recognized, there is still a lot of research work to be done in order to explore and understand the complex relationship among different formulation factors, film mechanical properties, and their bioperformance.

This Special Issue aims to compile the most recent findings related to ODF development and characterization and extend the knowledge base, which would facilitate future product development. Contributions related to different aspects of ODF development, including different approaches to increase drug load and incorporate poorly soluble drugs; applicability of different manufacturing methods and their potential scale-up to industrial level; development of relevant in vitro, in vivo, and in silico methods for ODF characterization and bioperformance prediction are welcomed.

Prof. Dr. Jelena Parojčić
Guest Editor

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Keywords

  • orally disintegrating films
  • pharmaceutical development
  • film forming polymers
  • additive manufacturing
  • in vitro, in vivo, and in silico characterization
  • scale-up
  • bioperformance

Published Papers (5 papers)

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Research

21 pages, 3425 KiB  
Article
The Impact of the Preparation Method on the Properties of Orodispersible Films with Aripiprazole: Electrospinning vs. Casting and 3D Printing Methods
by Ewelina Łyszczarz, Witold Brniak, Joanna Szafraniec-Szczęsny, Tomasz M. Majka, Dorota Majda, Marta Zych, Krzysztof Pielichowski and Renata Jachowicz
Pharmaceutics 2021, 13(8), 1122; https://doi.org/10.3390/pharmaceutics13081122 - 22 Jul 2021
Cited by 24 | Viewed by 3060
Abstract
Orodispersible films (ODFs) address the needs of pediatric and geriatric patients and people with swallowing difficulties due to fast disintegration in the mouth. Typically, they are obtained using the solvent casting method, but other techniques such as 3D printing and electrospinning have already [...] Read more.
Orodispersible films (ODFs) address the needs of pediatric and geriatric patients and people with swallowing difficulties due to fast disintegration in the mouth. Typically, they are obtained using the solvent casting method, but other techniques such as 3D printing and electrospinning have already been investigated. The decision on the manufacturing method is of crucial importance because it affects film properties. This study aimed to compare electrospun ODFs containing aripiprazole and polyvinyl alcohol with films prepared using casting and 3D printing methods. Characterization of films included DSC and XRD analysis, microscopic analysis, the assessment of mechanical parameters, disintegration, and dissolution tests. Simplified stability studies were performed after one month of storage. All prepared films met acceptance criteria for mechanical properties. Electrospun ODFs disintegrated in 1.0 s, which was much less than in the case of other films. Stability studies have shown the sensitivity of electrospun films to the storage condition resulting in partial recrystallization of ARP. These changes negatively affected the dissolution rate, but mechanical properties and disintegration time remained at a desirable level. The results demonstrated that electrospun fibers are promising solutions that can be used in the future for the treatment of patients with swallowing problems. Full article
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16 pages, 3207 KiB  
Article
Impact of Mixing on Content Uniformity of Thin Polymer Films Containing Drug Micro-Doses
by Guluzar G. Buyukgoz, Jeremiah N. Castro, Andrew E. Atalla, John G. Pentangelo, Siddharth Tripathi and Rajesh N. Davé
Pharmaceutics 2021, 13(6), 812; https://doi.org/10.3390/pharmaceutics13060812 - 29 May 2021
Cited by 3 | Viewed by 3087
Abstract
The impact of mixer type and critical process parameters (CPPs) on critical quality attributes (CQAs), including the drug content uniformity (CU) of slurry-cast polymer films loaded with micro-sized poorly water-soluble drugs were investigated. Previously untested hypothesis was that the best mixer at suitable [...] Read more.
The impact of mixer type and critical process parameters (CPPs) on critical quality attributes (CQAs), including the drug content uniformity (CU) of slurry-cast polymer films loaded with micro-sized poorly water-soluble drugs were investigated. Previously untested hypothesis was that the best mixer at suitable CPPs promotes uniform drug dispersion within film precursors leading to acceptable dried-film CU at low, ~0.6 wt% drug concentrations. Taguchi design was utilized to select the best of three mixers; low-shear impeller, high-shear planetary, and high-intensity vibrational, for dried-film drug concentration of ~23 wt%. As-received fenofibrate, a model poorly water-soluble drug (~6 µm) was directly mixed with the hydroxypropyl methylcellulose (HPMC) and glycerin aqueous solution. Impeller and planetary mixers yielded desirable film relative standard deviation (RSD), while vibrational mixer could not. For the lowest dried-film drug concentration of ~0.6 wt%, only planetary mixer yielded RSD <6%. The precursor drug homogeneity was a sufficient but not a necessary condition for achieving dried-film RSD <6%. Thus, proper selection of mixer and its CPPs assured desirable film CQAs. However, minor drug particle aggregation was identified via re-dispersion testing which also led to incomplete drug release. Full article
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18 pages, 2995 KiB  
Article
Formulation and Optimization of Sodium Alginate Polymer Film as a Buccal Mucoadhesive Drug Delivery System Containing Cetirizine Dihydrochloride
by Krisztián Pamlényi, Katalin Kristó, Orsolya Jójárt-Laczkovich and Géza Regdon, Jr.
Pharmaceutics 2021, 13(5), 619; https://doi.org/10.3390/pharmaceutics13050619 - 26 Apr 2021
Cited by 31 | Viewed by 3867
Abstract
Currently, pharmaceutical companies are working on innovative methods, processes and products. Oral mucoadhesive systems, such as tablets, gels, and polymer films, are among these possible products. Oral mucoadhesive systems possess many advantages, including the possibility to be applied in swallowing problems. The present [...] Read more.
Currently, pharmaceutical companies are working on innovative methods, processes and products. Oral mucoadhesive systems, such as tablets, gels, and polymer films, are among these possible products. Oral mucoadhesive systems possess many advantages, including the possibility to be applied in swallowing problems. The present study focused on formulating buccal mucoadhesive polymer films and investigating the physical and physical–chemical properties of films. Sodium alginate (SA) and hydroxypropyl methylcellulose (HPMC) were used as film-forming agents, glycerol (GLY) was added as a plasticizer, and cetirizine dihydrochloride (CTZ) was used as an active pharmaceutical ingredient (API). The polymer films were prepared at room temperature with the solvent casting method by mixed two-level and three-level factorial designs. The thickness, tensile strength (hardness), mucoadhesivity, surface free energy (SFE), FTIR, and Raman spectra, as well as the dissolution of the prepared films, were investigated. The investigations showed that GLY can reduce the mucoadhesivity of films, and CTZ can increase the tensile strength of films. The distribution of CTZ proved to be homogeneous in the films. The API could dissolve completely from all the films. We can conclude that polymer films with 1% and 3% GLY concentrations are appropriate to be formulated for application on the buccal mucosa as a drug delivery system. Full article
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16 pages, 3909 KiB  
Article
An Investigation into Mechanical Properties and Printability of Potential Substrates for Inkjet Printing of Orodispersible Films
by Erna Turković, Ivana Vasiljević, Milica Drašković, Nataša Obradović, Dragana Vasiljević and Jelena Parojčić
Pharmaceutics 2021, 13(4), 468; https://doi.org/10.3390/pharmaceutics13040468 - 30 Mar 2021
Cited by 10 | Viewed by 1988
Abstract
Inkjet printing is novel approach in drug manufacturing that enables dispensing precise volumes of ink onto substrates. Optimal substrate properties including suitable mechanical characteristic are recognized as crucial to achieve desired dosage form performance upon administration. Identification of relevant quality attributes and their [...] Read more.
Inkjet printing is novel approach in drug manufacturing that enables dispensing precise volumes of ink onto substrates. Optimal substrate properties including suitable mechanical characteristic are recognized as crucial to achieve desired dosage form performance upon administration. Identification of relevant quality attributes and their quantification is subject of intensive scientific research. The aim of this work was to explore applicability of different materials as printing substrates and explore contribution of the investigated substrate properties to its printability. Substrates were characterized with regards to uniformity, porosity, disintegration time, mechanical properties and drug dissolution. Experimentally obtained values were mathematically transformed and the obtained results were presented as relevant radar charts. It was shown that structurally different substrates may be employed for orodispersible films inkjet printing. Main disadvantage of single-polymer films was low drug load, and their printability was dependent on film flexibility and mechanical strength. Structured orodispersible film templates exhibited favorable mechanical properties and drug load capacity. Wafer edible sheets were characterized with high mechanical resistance and brittleness which somewhat diminished printability, but did not hinder high drug load. Obtained results provide insight into application of different materials as printing substrates and contribute to understanding of substrate properties which can affect printability. Full article
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19 pages, 1527 KiB  
Article
Mucoadhesive Gelatin Buccal Films with Propranolol Hydrochloride: Evaluation of Mechanical, Mucoadhesive, and Biopharmaceutical Properties
by Marija Jovanović, Nataša Tomić, Sandra Cvijić, Dušica Stojanović, Svetlana Ibrić and Petar Uskoković
Pharmaceutics 2021, 13(2), 273; https://doi.org/10.3390/pharmaceutics13020273 - 18 Feb 2021
Cited by 27 | Viewed by 5147
Abstract
This study processes and characterizes propranolol hydrochloride/gelatin mucoadhesive buccal films. Two types of gelatin are used: Gelatin from porcine skin, type A (GA), and gelatin from bovine skin (GB). The influence of gelatin type on mechanical, mucoadhesive, and biopharmaceutical characteristics of buccal films [...] Read more.
This study processes and characterizes propranolol hydrochloride/gelatin mucoadhesive buccal films. Two types of gelatin are used: Gelatin from porcine skin, type A (GA), and gelatin from bovine skin (GB). The influence of gelatin type on mechanical, mucoadhesive, and biopharmaceutical characteristics of buccal films is evaluated. Fourier-Transfer infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) analysis show that GA with propranolol hydrochloride (PRH) in the film (GAP) formed a physical mixture, whereas GB with PRH (GBP) form a compound-complex. Results of mechanical testing (tensile test, hardness) revealed that GAP films exhibit higher elastic modulus, tensile strength, and hardness. A mucoahesion test shows that GBP has higher adhesion strength, while GAP shows higher work of adhesion. Both in vitro release study and in silico simulation indicated that processed films can provide effective drug transport through the buccal mucosa. In silico simulation shows improved bioavailability from buccal films, in comparison to the immediate-release tablets—indicating that the therapeutic drug dose can be markedly reduced. Full article
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